Industry clinical trials

Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Examples include Expanded access, compassionate use, and humanitarian use studies. Generally, industry sponsored clinical trials are funded by pharmaceutical companies and are based on its protocol. Most clinical trial sponsors require a confidentiality agreement CDA before sharing protocols or other proprietary information. If this information is not complete on the eGC1, the agreement will be delayed until OSP receives them. The UW has Master Clinical Trial Agreements with many pharmaceutical and medical device companies conducting clinical trial research.

Clinical trials provide another option when standard therapy has failed. Others participate in trials because they want to contribute to the advancement of medical knowledge. All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history, and other medical conditions. This helps to reduce the variation within the study and to ensure that the researchers will be able to answer the questions they plan to study.

Therefore, not everyone who applies for a clinical trial will be accepted. It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people, because different people may respond differently to treatments. FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. Clinical trials can be sponsored by organizations such as a pharmaceutical company , Federal offices and agencies such as the National Institutes of Health or the U.

Department of Veterans Affairs , or individuals such as doctors or health care providers. The sponsor determines the location s of the trials, which are usually conducted at universities, medical centers, clinics, hospitals, and other Federally or industry-funded research sites.

FDA works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study.

The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Premarketing Risk Assessment.

Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. Pharmacogenomic Data Submissions. General Principles of Software Validation. Evaluation of Gender Differences in Clinical Investigations. Cooperative Research. Charging for Investigational Products. Recruiting Study Subjects. Screening Tests Prior to Study Enrollment.

Informed Consent, A Guide to.